Pharmacovigilance (PV) in Russia is a critical component of the national healthcare system, designed to ensure the safety, efficacy, and quality of medicines throughout their lifecycle. Governed by the Ministry of Health (MoH) and the Federal Service for Surveillance in Healthcare (Roszdravnadzor), Russia’s PV system has evolved to align more closely with international standards such as those established by the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH).

1. Regulatory Framework and Authorities

1.1 Key Regulatory Bodies

• Roszdravnadzor (Federal Service for Surveillance in Healthcare):
  The primary authority responsible for pharmacovigilance oversight, inspections, and enforcement of compliance with PV regulations.
• Ministry of Health (MoH):
  Establishes the regulatory framework, issues orders, and approves PV guidelines and procedures.

1.2 Core Legislative Documents

Pharmacovigilance activities in Russia are primarily regulated under:

• Federal Law No. 61-FZ “On Circulation of Medicines” (2010): Defines PV obligations for MAHs and healthcare institutions.
• Order No. 1071n (2016): Establishes the “Rules for Pharmacovigilance” outlining the structure of the national PV system.
• Order No. 200n (2019): Provides detailed requirements for adverse reaction reporting and risk management.

These regulations apply to both domestic and foreign MAHs marketing medicinal products in Russia.

2. Roles and Responsibilities

2.1 Marketing Authorization Holders (MAHs)

MAHs bear the principal responsibility for ensuring continuous monitoring of the safety profile of their products. Their key obligations include:

• Maintaining a pharmacovigilance system master file (PSMF) localized in Russia.
• Appointing a Qualified Person for Pharmacovigilance (QPPV) — a Russia-based specialist responsible for oversight of PV activities.
• Submitting Individual Case Safety Reports (ICSRs) to Roszdravnadzor within prescribed timelines.
• Conducting periodic safety update reports (PSURs) and risk-benefit assessments.
• Implementing and updating Risk Management Plans (RMPs) in accordance with regulatory requirements.

2.2 Healthcare Professionals

Doctors, pharmacists, and other healthcare providers play an essential role in PV by:

• Reporting suspected adverse reactions through national reporting portals or directly to the MAH.
• Participating in post-marketing safety surveillance studies.
• Assisting in identifying safety signals in real-world settings.

2.3 Roszdravnadzor

The regulatory authority:

• Receives and assesses ADR reports.
• Conducts inspections of MAH PV systems.
• Evaluates PSURs and RMPs.
• Issues safety communications or restrictions when a risk signal is confirmed.

3. Adverse Event Reporting Requirements

3.1 Reporting Timelines

• Serious ADRs: Must be reported within 15 calendar days of initial receipt.
• Non-serious ADRs: Must be reported within 90 calendar days.
• Reports must be submitted electronically via the Roszdravnadzor online platform or compatible E2B (R3) format.

3.2 Reportable Cases

All adverse reactions that occur:

• Within Russia, regardless of product authorization status.
• Outside Russia, if associated with a product authorized for the Russian market.

4. Risk Management and Safety Monitoring

4.1 Risk Management Plans (RMPs)

RMPs are mandatory for all new drug applications and must be submitted in Russian language. They include:

• Safety specification and identified risks.
• Pharmacovigilance plan outlining activities to monitor and minimize risks.
• Risk minimization measures tailored to the Russian healthcare context.

4.2 Periodic Safety Update Reports (PSURs)

MAHs must submit PSURs in line with the Eurasian Economic Union (EAEU) guidelines:

• Frequency: Generally, every six months post-authorization, then annually or as directed.
• Format: Follows ICH E2C(R2) standards.
• Content: Includes benefit-risk evaluation, cumulative safety data, and signal assessments.

4.3 Signal Detection and Assessment

MAHs and Roszdravnadzor collaboratively monitor safety data for new or changing risks. Identified signals may lead to:

• Label updates.
• Communication of safety alerts.
• Product withdrawal if necessary.

5. Inspections and Compliance

5.1 Roszdravnadzor Inspections

Inspections ensure that MAHs maintain a compliant and functional PV system. These audits may be:

• Planned: Routine, based on risk assessment.
• Unplanned: Triggered by safety concerns or non-compliance reports.

6. Integration with EAEU Pharmacovigilance System

Since Russia is part of the Eurasian Economic Union (EAEU), its PV system is harmonized with regional guidelines. The EAEU PV framework promotes:

• Unified reporting formats (E2B R3).
• Common PSUR submission schedules.
• Coordinated signal management and safety communication among member states.

This integration enhances consistency and cross-border drug safety monitoring across the region.

Key Takeaways

• Russia’s pharmacovigilance system is governed mainly by Federal Law No. 61-FZ and Orders 1071n & 200n.
• Roszdravnadzor is the key regulatory authority overseeing PV compliance.
• MAHs must appoint a local QPPV, maintain a Russian PSMF, and report ADRs within strict timelines.
• RMPs and PSURs are mandatory, following EAEU harmonized standards.
• Regular inspections and audits ensure compliance, with penalties for violations.
• The Russian PV framework continues to align with international best practices, emphasizing patient safety and regulatory transparency.

Authored By : Hassene Mokaadi
BPharm-Senior Project Manager, Baupharma.